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A reference material for harmonisation of D-dimer assays

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Author: Nieuwenhuizen, W.
Type:article
Date:1997
Institution: Gaubius Instituut TNO
Source:Thrombosis and Haemostasis, 5, 77, 1031-1033
Identifier: 233901
doi: doi:10.1055/s-0038-1656098
Keywords: Antifibrinolytic Agents · Female · Fibrin Fibrinogen Degradation Products · Humans · Immunoenzyme Techniques · Laboratories · Male · Netherlands · Reference Standards · Regression Analysis

Abstract

The term 'D-dimer assay' suggests, that these assays report the concentrations of the end-stage degradation product of crosslinked fibrin. This hardly occurs in patients. Degradation products of crosslinked fibrin rather occur with a wide range of molecular weights, and comprise various numbers of the D-dimer motif. Moreover, the numerical values obtained with different 'D-dimer' assays vary widely. The variations are probably due to differences in reactivity of the various monoclonal antibodies used with the various D-dimer containing degradation products as they occur in patients; and to the various calibrators with a value assigned by the manufacturers. For the reasons indicated above a calibrator in the strict sense (e.g. pure D-dimer) is not feasible. This study shows that: it appears feasible to generate a conversion factor for each of the 'D-dimer' assays studied, which will make the widely varying results obtained with these kits comparable; that the conversion factors can be based on a pool of real patient samples; and that the conversion factors are pool-independent. The next and final step in this study is to prepare and make available an international reference material for use by manufacturers and others facing a comparison problem. This is being carried out, in collaboration with the NIBSC (Dr. P. Gaffney), and the material is expected to be available in early 1997. Copyright © 1997 Schattauer Verlag